Prospective, Multicenter, 60 Months, Single Arm Cohort Study to Evaluate the Efficacy and Safety of the Ultra-Light-Weight Mesh CAlistar S in Transvaginal Pelvic Organ Prolapse Repair
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Promedon
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Number of Patients with Cure of pelvic organ prolapse
研究概览
简要总结
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
详细描述
Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse).
The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is approved in accordance with the CE Directive 93/42/EEC.
The utilization of synthetic implants in POP repair became increasingly popular in the last decade. The cumulative success rate of synthetic implants in anterior compartment repair is as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event reporting after unreflected utilization of meshes which raised concerns of patients safety; furthermore taking into account the complexity of adverse event mesh management. This led to a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further development of light weight meshes, the experience of the surgeon and the assessment and patients selection are well known factors reducing the rate of adverse events significantly.
Therefore, in the current trial the efficacy and safety of calistar S in a highly selected patient population will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinded POP-Q Examination: The POP-Q examination will be performed by a physician different to the corresponding surgeon
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-fertile women > 18 years1
- •Symtomatic anterior prolapse with or without apical vaginal wall involvement according POP-Q score ≥
- •(Corresponding to Aa, Ba ≥ -1 and where applicable C ≥ -1/2 TVL ).
- •Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.
- •Scheduled mesh-augmented anterior POP repair with Calistar S
- •Signed inform consent
排除标准
- •Fertile women
- •Patients with active or latent infection of the vagina, cervix or uterus
- •Patients with previous or current vaginal, cervical or uterine cancer
- •Previous, current or planned pelvic radiation therapy
- •Known allergy to polypropylene
- •Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent
结局指标
主要结局
Number of Patients with Cure of pelvic organ prolapse
时间窗: 24 months
Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components
次要结局
- Patient subjective evaluation of POP severity according the Global Impression of Severity(Baseline)
- Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up(Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months)
- Anatomical success according the number of patients with anterior vaginal wall at or above the hymen and no decent of apical vaginal wall at or greater than half of the total vanilla lengths(6 weeks and 6, 12, 24, 36, 48, 60 months)
- Number of patients with necessity of repeated surgery due to recurrent anterior or apical Number of patients with Repeat surgery due to symptomatic recurrence of anterior or apical POP(6 weeks and 6, 12, 24, 36, 48, 60 months)
- Safety of Calistar S according the number of adverse events(intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits)
- Exposure and anatomical-failure free survival(12, 24, 36, 48, 60 months)
- Number of patients with further surgery for stress urinary incontinence(6 weeks and 6, 12, 24, 36, 48, 60 months)
- Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up(Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months)
- Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up(Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months)
- Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up(Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months)
- Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up(Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months)
- Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up(Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months)
- Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement(6 weeks and 6, 12, 24, 36, 48, 60 months)
- Cure in short-, mid-, and longterm follow-up(6 weeks and 6, 12, 36, 48, 60 months)